A Trial Comparing Routine Versus Selective Use of Completion Angiography After Surgical Thromboembolectomy in the Treatment of Acute Lower Limb Ischemia and Their Impacts on Limb Salvage Rates

Mansoura University

Status: Completed

Conditions: Acute Limb Ischemia

Treatments: Procedure: completion angiography followed by endovascular treatment of residual or underlying lesions

Study type: Interventional

Funder types: Other

Identifiers

NCT03388021

MD/85

Details and patient eligibility

About

this randomized controlled trial will compare the impact of routine use of completion angiography versus using it on selective bases after thromboembolectomy in patients with acute lower limb ischemia and their impact on limb salvage rates

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Grade I (1) (viable) acute ischemia which there is no immediate threat of limb loss; the patient is presented with neither sensory nor motor weakness and there are audible Doppler signals in both arteries and veins.
• Grade IIA (2 A) (marginally threatened) acute ischemia which needs proper treatment to save the limb; the patient is presented with a minimal sensory loss, no motor weakness, inaudible arterial Doppler signals but the venous Doppler signals are still audible.
• Grade IIB (2 B) (immediately threatened) acute ischemia which needs immediate revascularization to save the limb; the patient is presented with a sensory loss associated with rest pain, mild to moderate motor weakness, inaudible arterial Doppler signals but the venous Doppler signals are still audible.

Exclusion criteria

• Traumatic or iatrogenic acute limb ischemia
• Grade III acute ischemia (irreversible) with major tissue loss and major amputation is inevitable; the patient presented with sensory and motor loss, inaudible arterial and venous Doppler signals.
• Patients With occluded bypass graft.
• Acute limb ischemia due to intra-arterial injection
• Patients with chronic renal impairment (serum creatinine > 1.2) or with a history of contrast-induced nephropathy.
• Acute lower limb ischemia due to thrombosed aneurysms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

routine use of completion angiography after thromboembolectomy

Experimental group

Description:

this group will undergo surgical revascularization followed by routine completion angiography assisted with one of these adjuvant techniques as: 1. Thromboembolectomy under fluoroscopic guidance using Fogarty over the wire 2. Balloon angioplasty and/or stenting 3. Intraarterial thrombolysis Aiming to correct any residual angiographic lesion as: 1. Residual thrombus 2. Retained embolus 3. Atheromatous plaque

Treatment:

Procedure: completion angiography followed by endovascular treatment of residual or underlying lesions

if the results were not satisfactory intraoperatively as fail

Active Comparator group

Description:

this group will undergo surgical thromboembolectomy. if the results were not satisfactory intraoperatively as failure to advance the Fogarty catheter or to get satisfactory inflow or backflow or Extraction of intimal fragments.patient will undergo diagnostic angiography and endovascular or surgical intervention according to result of diagnostic angiography.

Treatment:

Procedure: completion angiography followed by endovascular treatment of residual or underlying lesions